FDA 510(k) Application Details - K981407

Device Classification Name Catheter, Angioplasty, Peripheral, Transluminal

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510(K) Number K981407
Device Name Catheter, Angioplasty, Peripheral, Transluminal
Applicant CORDIS CORP.
14201 N.W. 60TH AVE.
MIAMI LAKES, FL 33014 US
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Contact MIRJAM BARBOZA
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Regulation Number 870.1250

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Classification Product Code LIT
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Date Received 04/20/1998
Decision Date 05/20/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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